EpiVacCorona

EpiVacCorona (Russian: ЭпиВакКорона, tr. EpiVakKorona) is a COVID-19 vaccine developed by the Vector Institute.[1][2][3] The EpiVacCorona vaccine contains fragments extracted from the virus synthetic peptide antigens. The antigens-based vaccine provokes an immune reaction against COVID-19 and promotes the further development of immunity.[4] Questions and concerns by journalists and public were raised about data access from the vaccine's clinical trials.[5]

EpiVacCorona
Vaccine description
TargetSARS-CoV-2
Vaccine typePeptide subunit
Clinical data
Trade namesEpiVacCorona
Routes of
administration		Intramuscular
ATC code
  • None
Legal status
Legal status
  • Registered in Russia on 14 October 2020 RU Registered.TUapproved.
Identifiers
DrugBank
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Description

EpiVacCorona is a peptide antigens-based vaccine.[6] Thus, the vaccine does not contain the live virus and forms immunity due to the use of artificially synthesized peptides.[7]

Development

In March 2020, it was reported that Russian scientists have begun to test vaccine prototypes for the new coronavirus disease, with the plan of presenting the most effective one in June, a laboratory chief at Vector Institute said. The prototypes have been created and the testing on animals began.[8]

In July 2020, researchers from the Vector Institute found that the SARS-CoV-2 virus that causes COVID-19 can be killed in room temperature water within 72 hours, helping further research about the disease during the pandemic.[9][10] The large-scale production of the EpiVacCorona vaccine, according to Russian Prime Minister Mikhail Mishustin, will begin in February.[11]

Data on 86 participants in a phase I–II trial were published in Russian Journal of Infection and Immunity, indicating preliminary evidence of safety and an immune response.[12]

Authorization

Authorization by country
  Full authorization
  Emergency authorization

On 14 October 2020, President Vladimir Putin announced that the vaccine was approved.[17]

As of March 2021, Turkmenistan became the only foreign state to register Russian vaccine on its territory.[18]

Questions and concerns

A lot of concerns were made by journalists and public. Participants of the third phase of post-registration clinical trials "EpiVacCorona" addressed an open letter to the Ministry of Health, Rospotrebnadzor and "Vektor". They claim that in their sample, more than 50% of those who documented their participation in the study received negative tests for antibodies, although only 25% of the participants should have had a placebo. Vector Institute claims that it is possible to detect the required antibodies only by their test system, but it keeps it secret.[19][20][21]

The vaccine was patented on December 7, 2020.[22] Among the authors are 12 people, one of whom is a namesake of the head of Rospotrebnadzor,[23] which can be an issue because it's a governmental structure that approves vaccine-candidates.

References
  1. "Study of the Safety, Reactogenicity and Immunogenicity of "EpiVacCorona" Vaccine for the Prevention of COVID-19 (EpiVacCorona)". ClinicalTrials.gov. United States National Library of Medicine. 22 September 2020. NCT04368988. Retrieved 16 November 2020.
  2. "Russian EpiVacCorona Vaccine Has No Adverse Effects". OREANDA-NEWS. 13 January 2021.
  3. "Over 1,400 volunteers get Russia's first EpiVacCorona vaccine jab". TASS. 15 December 2020.
  4. "State Research Center of Virology and Biotechnology: COVID-19 Vaccine Patented". Federal Service for Intellectual Property. 30 September 2020. Retrieved 17 January 2021.
  5. https://science.sciencemag.org/content/372/6538/116
  6. "Russia's EpiVacCorona vaccine post-registration trials started". www.thepharmaletter.com.
  7. "Russia's EpiVacCorona vaccine post-registration trials started". www.thepharmaletter.com.
  8. "Russia to test coronavirus vaccine prototype on animals". Retrieved 17 March 2020.
  9. "Scientists figure out a weakness of coronavirus: Ordinary water". mint. 1 August 2020. Retrieved 23 September 2020.
  10. "Water at boiling temperature can completely destroy novel coronavirus, say Russian scientists". www.timesnownews.com. Retrieved 23 September 2020.
  11. https://business.com.tm/post/6607/turkmenistan-approves-use-of-russias-epivaccorona-vaccine
  12. Ryzhikov AB, Ryzhikov EA, Bogryantseva MP, Usova SV, Danilenko ED, Nechaeva EA, Pyankov OV, Pyankova OG, Gudymo AS, Bodnev SA, Onkhonova GS, Sleptsova ES, Kuzubov VI, Ryndyuk NN, Ginko ZI, Petrov VN, Moiseeva AA, Torzhkova PY, Pyankov SA, Tregubchak TV, Antonec DV, Gavrilova EV, Maksyutov RA (2021). "A single blind, placebo-controlled randomized study of the safety, reactogenicity and immunogenicity of the "EpiVacCorona" Vaccine for the prevention of COVID-19, in volunteers aged 18–60 years (phase I–II)". Russian Journal of Infection and Immunity. 11 (2): 283–296. doi:10.15789/2220-7619-ASB-1699.
  13. "Turkmenistan registers vaccines for the prevention of infectious diseases". Turkmenistan Today. 29 January 2021.
  14. "Russian vaccine "EpiVacCorona" was registered in Turkmenistan". EN24. 29 January 2021.
  15. "О регистрации вакцины ФБУН ГНЦ ВБ "Вектор" Роспотребнадзора "ЭпиВакКорона"". Rospotrebnadzor (in Russian). 14 October 2020.
  16. "Russia's EpiVacCorona vaccine post-registration trials started". The Pharma Letter. 18 November 2020.
  17. "Совещание с членами Правительства". President of Russia. 14 October 2020.
  18. "Turkmenistan registers vaccines for the prevention of infectious diseases". Turkmenistan Today. 29 January 2021.
  19. О. Дьяконова (13 February 2021). "Нет антител, вопросы к составу, непрозрачность данных. Что не так с вакциной "ЭпиВакКорона"". BBC (in Russian). Retrieved 13 February 2021.
  20. https://epivakorona.com/openletter.htm
  21. https://www.sciencemag.org/news/2021/04/russia-s-covid-19-defense-may-depend-mystery-vaccine-former-bioweapons-lab-does-it-work
  22. https://new.fips.ru/ofpstorage/Doc/IZPM/RUNWC1/000/000/002/738/081/%D0%98%D0%97-02738081-00001/document.pdf
  23. "Вакцина-плацебо от Роспотребнадзора – МБХ медиа". 20 February 2021.
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